The use of single-use plastic bags in the biological manufacturing, blood-banking and other tissue and cell culture processing is fast becoming the most desirable method as their use obviates the need to clean the vessels and validate them for future operations; with increased demand by the regulatory authorities to provide cleaning validation proof, particularly those of freedom from viruses, it is anticipated that soon, because of higher cost of validation, most of the biological reaction and storage processes will be carried out in single-use flexible plastic bags.
A large number of commercial suppliers are currently marketing these single-use flexible plastic bag systems for biological manufacturing as well as storage of biological fluids such as blood bags; of prime interest to this invention are the mixing systems offered by GE Healthcare as the Wave Bag system wherein a two-dimensional bag is affixed to a rocking platform to mix the contents to produce biological compositions such as culture media and when fitted with appropriate systems, to induce bioreaction in the presence of necessary nutrients and biocatalysts. The U.S. Pat. No. 6,190,913 to Vijay Singh describes the details of the Wave system currently marketed by GE Healthcare. The GE Healthcare Wave Cellbag is intended to be used with a gentle motion and as a result it has been recommended by the manufacturer not to use the system for reactions requiring more vigorous mixing such as required in the fermentation using bacteria or other organisms or cells severely limiting the use of the Wave Cellbag and other similar apparatus in the commercial manufacture of biological products.
Another competing technology utilizes flexible bags attached with stirrers and other implements similar to what is used in the traditional stainless steel fermentors or mixers. In some instances, mixing is achieved by a variety of aeration mechanisms along with mechanical mixing but until now no invention has described a stationary system that will induce mixing inside flexible bags such that the size of the bag can be infinitely variable and the nature and intensity of mixing adjustable to the need of the bioreaction.